Comparison of analgesic effect - the combination of acetaminophen and ibuprofen in the presence and absence of caffeine on pain after root canal treatment
Pain following the root canal treatment is an important problem for the patients and dentists. Caffeine is an alkaloid that used with other analgesic to increase their effects. The goal of this study was comparing the analgesic effect of Acetaminophen & Ibuprofen combination in the presence and absence of Caffeine after root canal treatment. In this study, 45 patients that referred to the root canal treatment ward of Babol Dental College had been studied. The inclusion criteria: patients who need to treat one of their molar teeth with spontaneous pain with severity of at least grade 4 according to VAS). At the end of the first session that was preparation of the access cavity and instrumentation of all canals till master apical file (MAF). The patients were taken one of three drug regimen (single dose) of the study as below: 1-Acetaminophen 325mg, Ibuprofen 200mg with caffeine 40mg [Novafen known named field (the construction company (Brown & burk (uk]; 2-Acetaminophen 325mg, Ibuprofen 200mg and 3-Placebo. Then the patients record their severity of pain after 4-6-12-24-48-72 hours after using the drugs, according to the VAS. Meanwhile the patients received a drug pocket that contains 2 tab of Acetaminophen to use if their pain is continuous. In the second session, the canals filled with gutta-percha and ZOE sealer and referred to restore. The data were analyzed with ANOVA test and SPSS software.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201306121760N24
Registration date:2013-10-27, 1392/08/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-10-27, 1392/08/05
Registrant information
Name
Nargess Gholizadeh Pasha
Name of organization / entity
Fatemehzahra Infertility Reproductive Health Research Center, Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 2282
Email address
zahra@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Expected recruitment start date
2007-09-23, 1386/07/01
Expected recruitment end date
2008-04-20, 1387/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of analgesic effect - the combination of acetaminophen and ibuprofen in the presence and absence of caffeine on pain after root canal treatment
Public title
Comparison of analgesic effect - the combination of acetaminophen and ibuprofen in the presence and absence of caffeine on pain after root canal treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with pain origin molars; patients with spontaneous pain (moderate to severe) based on the criterion of a minimum of four (VAS); patients in the age group 65-18 years old.
Exclusion criteria: systemic disease; housing consumption in the last 12 hours; history of allergy to NSAIDs and drugs; pregnant and lactating patients.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The ethics committee of Babol University of Medical sciences
Street address
Babol University of Medical sciences, Ganjafroz Avenue
City
Babol
Postal code
Approval date
2007-08-23, 1386/06/01
Ethics committee reference number
1439
Health conditions studied
1
Description of health condition studied
Pain of acute apical periodontitis
ICD-10 code
K04.4
ICD-10 code description
Acute apical periodontitis of pulpal origin
Primary outcomes
1
Description
Pain after root canal treatment
Timepoint
4, 6, 12, 24, 48 and 72 hours after intervention
Method of measurement
Visual Analog Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Group intervention 1:
Acetaminophen 325 mg, Ibuprofen 200 mg and caffeine 40 mg [Novafen known named field (the construction company (Brown & burk (uk];
By the Laboratory of Pharmacology, Faculty of Medicine, Babol University of Medical Sciences were divided into three groups of 15.
The same drug in capsules (made from gelatin and orange) were placed inside the envelope of a single dose were quite similar and alike.
Category
Treatment - Drugs
2
Description
Group intervention 2:
Acetaminophen 325 mg, Ibuprofen 200 mg.
By the Laboratory of Pharmacology, Faculty of Medicine, Babol University of Medical Sciences were divided into three groups of 15.
The same drug in capsules (made from gelatin and orange) were placed inside the envelope of a single dose were quite similar and alike.
Category
Treatment - Drugs
3
Description
Group Control:
placebo.
By the Laboratory of Pharmacology, Faculty of Medicine, Babol University of Medical Sciences were divided into three groups of 15.
The same drug in capsules (made from gelatin and orange) were placed inside the envelope of a single dose were quite similar and alike.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
The root canal, dental faculty
Full name of responsible person
Mohammad-Kazem Mostafavi
Street address
Vice Chancellor for Research and Technology, Babol University of Medical Sciences, Ganjafroz Avenue
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Bijani
Street address
Vice Chancellor for Research and Technology, Babol University of Medical Sciences, Ganjafroz Avenue
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Dental College of Babol
Full name of responsible person
Roghayeh Naeimi Tabiei
Position
Dental students
Other areas of specialty/work
Street address
Ganjafroz Avenue, Babol University of Medical Sciences, Dental College
City
Babol
Postal code
Phone
+98 11 1229 1408
Fax
Email
naeimi.shabnam@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental College of Babol
Full name of responsible person
Dr. Zahra-Sadat Madani
Position
Endodontist
Other areas of specialty/work
Street address
Ganjafroz Avenue , Babol University of Medical Sciences, Dental College
City
Babol
Postal code
Phone
+98 11 1229 1408
Fax
Email
naeimi.shabnam@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences and Research Centre
Full name of responsible person
Nargess Gholizadeh Pasha
Position
M.A
Other areas of specialty/work
Street address
City
Babol
Postal code
Phone
+98 11 1227 4881
Fax
Email
ngh_pa@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)